All posts for the month January, 2015

Bernie Monegain is the Editor-at-Large of Healthcare IT News. Bernie covers hospitals and IDNs and industry trends.

ONC-funded study offers new approach for taking measure

The uptake of healthcare information technology, especially EHRs, has been rapid, but how to measure the value? So far, in spite of several studies, none has been able to assess health IT’s true effect on the healthcare system, according to an ONC-funded study published online by the American Journal of Care Management on Jan. 26.

The study’s authors over a three-part framework for measuring the value of healthcare IT:

Value includes both costs and benefits;

Value accrues over time; and

Value depends on which stakeholder’s perspective is used.

“Unfortunately, we have found that few studies include both costs and benefits in their definitions of value,” the authors wrote. “Most studies look at only short-term time horizons, which ignore many of the downstream benefits of the HIT, and many studies don’t even explicitly state to whom the value is accruing.”

“Without more attention to the necessary measuring and reporting of the data needed to assess value,” they add, “we risk the possibility of three more years’ worth of published studies, which we estimate would be more than 300 hypothesis-testing articles that do not give us appreciably better knowledge about this crucial aspect of HIT: how best to realize value.”

“Through examples, we show how these principles can be used to guide and improve HIT evaluation studies,” they wrote. The study presents a checklist enumerating contextual and implementation characteristics that are important for interpretation of results. “These improvements will make future studies more useful for policymakers and more relevant to the current needs of the healthcare system,” the authors added.

The Office of the National Coordinator for Health IT has released for public comment its shared nationwide roadmap for interoperability.

The roadmap’s goal is to provide steps to be taken in both the private and public sectors to create an interoperable health IT ecosystem over the next 10 years, according to ONC.

One of the main focuses on the roadmap is to enable “a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017.”

“HHS is working to achieve a better healthcare system with healthier patients, but to do that, we need to ensure that information is available both to consumers and their doctors,” HHS Secretary Sylvia M. Burwell said in the announcement. “Great progress has been made to digitize the care experience, and now it’s time to free up this data so patients and providers can securely access their health information when and where they need it.”

Along with the roadmap, ONC also released a draft of 2015 Interoperability Advisory Standards, which “represents ONC’s assessment of the best available standards and implementation specifications for clinical health information interoperability as of December 2014.”

The roadmap is garnering praise from industry leaders, including from the College of Healthcare Information Management Executives. CHIME said in an annocement that is “welcomes” the Interoperability Standards Advisory today as part of the roadmap.

“This is a much-needed playbook for each and every health IT professional,” CHIME President and CEO Russell P. Branzell said in the announcement. “Now, healthcare providers and health IT developers have a single source of truth, with an extensible process to align clinical standards towards improved interoperability, efficiency and patient safety. While we have made great strides as a nation to improve EHR adoption, we must pivot towards true interoperability based on clear, defined and enforceable standards.”

Trying to improve patient care coordination and clinical communication through current EHR systems is frustrating and difficult, according to the majority of physicians in a new Spyglass Consulting Group survey, and healthcare organizations are making it worse by not investing adequately in health IT infrastructure. As patient-centered and team-based care begin to demand more from staff members and technology alike, organizational leaders must focus on EHR interoperability, health information exchange, and improved data governance structures that foster an environment of simple and secure communication.

“Efficient communications and collaboration between physicians, specialists, nurses and care team members is critical to enhance patient safety, and support the coordination and delivery of patient care across health settings,” said Gregg Malkary, Managing Director of Spyglass Consulting Group. Despite the ubiquity of smartphone adoption among physicians, many EHRs do not fully support mobile communications, and 70 percent of physicians believe that their executive leaders are not investing enough time and money in communications infrastructure.

The average hospital loses $1.7 million per year due to inefficient care coordination, a Ponemon Institute and Imprivata study found earlier this year. More than half of the time involved in patient admissions, transfers, and discharges – revolves around waiting for responses from other members of the care team, averaging more than half an hour of idleness per patient. An increase in the adoption of secure text messaging and mobile access to EHR data may help to reduce these lengthy wait times, but many organizations still rely on somewhat more old fashioned methods of sharing information.

“Smartphones are preferred because they are easier to use and provide more enhanced functionality than outdated communication options provided by hospital IT including pagers, overhead paging systems, landline phones and fax machines,” Malkary says.

The Spyglass survey found that 83 percent of physicians were frustrated and disappointed by poor EHR usability, a lack of interoperability, and insufficient integration between the EHR and messaging infrastructure. Finding the right clinical data to flag or send was equally difficult, which contributed to the overwhelming sense that physicians are simply unprepared and unmotivated to adopt the principles and processes of collaborative care.

“As we were developing our plans for improving communication among clinicians, we discovered that few hospitals were investing in communication‐driven workflow support, perhaps because meaningful use and HIPAA are consuming all the resources,” explained Steven Davidson, MD, MBA, the former CMIO at Maimonides Medical Center in New York. “Still, it seems many IT leaders hope the EHR – a tool poorly suited to the task –will suffice. In reality, overwhelmed nurses and doctors struggle accomplishing necessary communication through the EHR; instead implementing workarounds on their own devices.”

If physicians and other members of staff have such difficulty communicating between themselves, it is perhaps unsurprising that they have equal trouble ensuring that a patient’s information reaches his or her primary care provider after discharge to ensure that care coordination continues beyond the hospital’s walls. A recent study from the American Heart Association found that 7.3% of discharge summaries were not sent to primary care providers until more than thirty days after the patient left the hospital, and were often lacking significant chunks of clinical information when they did arrive.

While patient navigators and automated care coordination programs may help patients understand and meet their responsibilities, hospitals and healthcare organizations will need to move beyond the EHR by adopting mobile communication technologies that meets the expectations of their physicians and drive organizational transformation as the healthcare industry increasingly relies on solid communications to achieve the benefits of accountable care.

Innovative new products can and do transform industries every day, and the pace of change has accelerated due to massive technological breakthroughs such as the internet, smartphones and wireless technology. But when it comes to innovation, not all industries are created equal.

The healthcare sector is highly complex, and the medical care delivery ecosystem is under increasing pressures due to rising costs and patient expectations. These pressures and the inherent nature of the industry itself make innovation in healthcare more complicated than in the consumer products sector.

To break through the complexity and move innovation in medicine forward, inventors and product research and manufacturing companies must first overcome the many barriers to healthcare product development. Here are 10 of the top barriers healthcare innovators regularly face.

1. Medical efficacy review

To be successful, a new healthcare innovation must improve upon the current standard of medical care without causing harm to the patient and ideally lower costs simultaneously. But gaining access to medical professionals with the appropriate specialised expertise to determine medical efficacy can pose a major obstacle to even the largest, most established companies, not to mention the individual inventor. The diverse sets of clinical expertise necessary to review projects are rarely found in-house and can be expensive to purchase from outsiders.

2. Product distribution

Unlike consumer products, healthcare products are distributed through a more complex supply chain that involves multiple parties, including medical device manufacturers and distributors, the NHS purchasing and supply agency, physicians and nurses who provide the product to the end user, and the patient, who generally has no input on product or pricing considerations. Determining how best to break into this elaborate network can be daunting, if not truly insurmountable for inventors.

3. Manufacturer access

Gaining access to quality manufacturers is a major hurdle for many healthcare inventors because of concerns that manufacturers have about “intellectual property contamination” issues. In this scenario, manufacturers avoid learning about an individual inventor’s idea since it may be too similar to an innovation their internal research and development team is already working on; manufacturers do not want to run the risk of having to later prove to the inventor (or to a judge) that the idea was not stolen.

4. Lack of access to NHS purchasing data

Even large, well-connected medical manufacturing companies may find it difficult to access purchasing and product needs data and input from NHS. And operating in the absence of this information makes accurately estimating product adoption rates and potential market size virtually impossible.

6. Intellectual property complexity

Intellectual property rights have always been a confusing aspect of the inventing process for the majority of individual inventors. It can be virtually impossible to navigate without professional help.

7. Healthcare culture

By nature and for good reason, the healthcare industry is incredibly risk averse. As one doctor said: “The moment we step into medical school, we are trained to identify the most statistically proven method for treating a particular disease, and we are taught to not deviate from that path until a better method has been found and proven.” Compounding this issue is the fact that the majority of healthcare workers are increasingly time-pressed today, and so learning and adopting new systems, new methods of care or new devices often take a backseat to day-to-day patient care.

8. High-stress environment

Healthcare workers have high-stress jobs and often work long hours. They are dedicated to delivering great patient care, but the nature of the job can make it difficult for innovative thinking to flourish, since creativity naturally diminishes when an individual is in steady “fight or flight mode”.

9. Complex value analysis model

In the healthcare sector, it is difficult for a product developer or individual inventor to generate data on how the product affects not only direct treatment but also the downstream healthcare supply chain, which means that determining the true value of a new innovation idea is difficult.

10. Misconceptions about what constitutes innovation

Within healthcare, those traditionally tasked with product development (ie engineers and technical experts) are generally not the same people who are actually living with or treating a particular healthcare challenge.

As this list demonstrates, there are numerous and significant barriers to healthcare innovation, but there are also common themes throughout: an industry that is evolving rapidly and a lack of centralised expertise that skews perspectives and limits resources. Consumer product inventors face many daunting challenges, but the institutional, industrial and knowledge barriers that confront innovators in the healthcare field are unique.

To truly optimise healthcare innovation, individual inventors and companies must find a way to overcome these barriers. A successful collaboration among all parties – manufacturers, providers, the NHS and patients – is critical.

Everyone who has a role in the healthcare delivery process and the influence necessary to bring about change must be invited to play a part, since only by combining each party’s respective strengths through collaboration can we overcome these hurdles and begin to deliver truly exceptional healthcare.

Interoperability was supposed to be a centerpiece of Stage 2 of the Meaningful Use (MU) EHR incentive program, but hospitals and physicians practices nationwide are finding out just how hard it is to achieve that goal. Through the end of August, a mere 25 hospitals and 1,277 eligible professionals had attested to Stage 2 on the Medicare side of the program, according to CMS.

A KLAS Enterprises report, released in October, found that although 82 percent of the 220 providers interviewed thought that they were at least “moderately successful” with interoperability, a mere 6 percent said they were at an “advanced” level. And just 20 percent were “optimistic” about health IT vendors’ efforts to collaborate on interoperability.

In the same week, the Office of the National Coordinator for Health Information Technology submitted its annual report to Congress, highlighting some of the problems. “Electronic health information is not yet sufficiently standardized to allow seamless interoperability, as it is still inconsistently expressed through technical and medical vocabulary, structure, and format, thereby limiting the potential uses of the information to improve health and care,” the report said.

Days later, ONC released an update of its proposed 10-year roadmap to interoperability, a document that will be finalized in 2015. Like the earlier draft, this version put interoperability front and center on the office’s three-year agenda, while harnessing this information to improve care and lower cost was part of the sixyear plan. This effectively pushes a main goal of Stage 2 into the third stage of MU, which will not start before 2017, and suggests that the bulk of the nation’s healthcare providers won’t achieve the “Triple Aim” until after the incentive money is gone.

Building Interoperability Around APIs

ONC’s Health IT Policy Committee and Health IT Standards Committee also approved recommendations from a task force of an independent scientific advisory group known as JASON (not an acronym, but a reference to a character in Greek mythology) to build interoperability around application programming interfaces (APIs). Together, the moves have gotten mixed reviews.

“Credit to ONC for the vision,” said Russell Branzell, CEO of the College of Healthcare Information Management Executives (CHIME). “We just need to find a way to do it faster than a 10-year plan.”

Branzell wondered how hospitals are supposed to balance the longer-term vision for interoperability with an MU timeline that penalizes noncompliant providers starting in 2015. “There still are some pieces fundamentally missing,” Branzell said.

He believes there should be “clearly enforceable standards” for patient matching, as well as “specific data standards that are enforceable down to the nomenclature number.” Not having standards — standards that are kept current — adds to the complexity of health information exchange by offering too many choices that are not always compatible with each other, according to Branzell.

The CHIME chief continued, calling patient matching “the cornerstone of not only effective patient exchange but also patient safety.” He would like at least a standardized patient matching requirement, if not a national patient identifier; a national ID has been politically taboo since at least 1998, even though the original 1996 HIPAA statute called for one.

Branzell praised the API strategy, while also indicating he was a proponent of the Fast Healthcare Interoperability Resources (FHIR) standard for data exchange, something created by Health Level 7 International. (Branzell is a member of the HL7 advisory board.)

The API idea is proving popular at the policy level. At a Washington, D.C. healthcare conference put on by U.S. News & World Report in October, Micky Tripathi, founding president and CEO of the Massachusetts eHealth Collaborative; Jennifer Covich Bordenick, CEO of eHealth Initiative; and Steven Posnack, director of ONC’s Office of Standards and Technology, all spoke in favor of greater availability of APIs in healthcare. After all, it has become common for facilitating interoperability in so many other industries.

Tripathi mentioned other interoperability vehicles, including secure messaging following Direct Project protocols, point-to-point query and retrieve — usually by organizations using the same EHR vendor — and record aggregation with data normalization. Central repositories, he said, “are the dinosaurs that are going to go away.”

Later, at the same event, then-National Health IT Coordinator Dr. Karen DeSalvo, said that EHRs would have limited impact on the quality of care in the absence of greater interoperability.

In the real world of healthcare, providers are getting creative, though some still want more clarity from Washington or from the health IT industry. Gulfport (MS) Memorial Hospital replaced its legacy EHR with a Cerner system that went live in June. Three months later, CIO Gene Thomas said that his most difficult task was migrating data to Cerner.

“This could have been avoided if all vendors had been told to adhere to the same formats,” Thomas said. “The lack of standards in healthcare is a problem.”

Addressing HIE Via Common Vendor Platforms Memorial Health System in Springfield, IL approached interoperability in what CIO Dr. David Graham called a “reverse way,” with private practices bringing data to the organization’s primary care group. Like so many other providers, Memorial is building a health information exchange among nearby organizations that have a common vendor, in this case, Allscripts Healthcare Solutions.

Memorial has been rolling out the Allscripts TouchWorks EHR at its own clinics this year and is installing an Allscripts interoperability platform called FollowMyHealth. The precursor of FollowMyHealth, called Jardogs, was incubated at the Springfield Clinic, a partner of Memorial Health System, prior to Allscripts acquiring the technology in early 2013.

Another partner, the Southern Illinois University School of Medicine, also is transitioning to TouchWorks for ambulatory clinics, Graham said. “We are competing practices using the same database and the same instance of TouchWorks,” he said.

Memorial also collaborates with a federally qualified health center (FQHC). When that safety-net facility refers patients to the Springfield Clinic or the SIU School of Medicine, information from a NextGen Healthcare Information Systems EHR flows into a common portal that care managers can access to reach out to high-risk patients, Graham said.

“The other benefit of it is that then you can put that data in front of the physician,” Graham said.

It’s not full interoperability, but it’s a start.

Adding Mobility To The Interoperability Equation

A much larger healthcare system, San Francisco-based Dignity Health, has made interoperability a major component of a massive IT program. Dignity Health, formerly known as Catholic Healthcare West, was the launch customer for AirStrip One, a product from San Antonio-based AirStrip Technologies that delivers data from EHRs, patient monitors, and medical devices to clinicians on their mobile phones and tablets. Dignity also made an unspecified investment in AirStrip in August.

“We’re fairly early with AirStrip One,” said Dr. Davin Lundquist, Dignity’s CMIO for population health. In the fourth quarter of 2014, the multistate health system was implementing the product in the Central Coast region of California. “In parallel with this, we are exploring care management, video visits, and other ways to engage patients,” Lundquist said. “You need to come at it from lots of angles.”

AirStrip OB, an obstetrics module, is in nearly every one of Dignity Health’s hospitals, and the health system also has begun using AirStrip’s cardiology product. “What we are envisioning is that we will get AirStrip in the hands of all of our physicians,” said Lundquist, a family physician in Camarillo, CA, who practices about one day a week. He expects to have secure clinician messaging within the apps as well.

There are a lot of physicians to reach. Dignity Health has approximately 1,200 employed physicians and 2,000 to 3,000 “clinically integrated” aligned physicians among its total medical staff of more than 10,000, according to Lundquist. “Our health system, like many others, relies on independent physicians to support our work,” he said.

Meanwhile, Dignity is about two-thirds of the way through migrating its hospitals to a Cerner EHR from an older system. Dignity Health Medical Foundation in California and several practices in the Phoenix area all run an Allscripts EHR, though Lundquist said there is “some variability” among those Allscripts installations.

Dignity has built a private health information exchange on the MobileMD platform, technology that Siemens bought in 2011 and now is in the process of selling to Cerner as part of the latter’s $1.3 billion acquisition of Siemens’ health IT business. More than 7,000 physicians across all of Dignity’s markets are connected, according to Lundquist. “In most cases, that allows them to access hospital information,” he said.

However, most of the data flow is one-way, though some employed physicians do have bidirectional exchange with Dignity Health hospitals. According to Lundquist, this is more a legal issue than a technical one. “Who owns it? Does it become part of the [patient’s] legal record? Do you become an HIO?” he wonders.

Dignity Health’s system connects with many national, standard HIE connections and exchanges data with the UC-Davis Medical Center and, according to Lundquist, is exploring a relationship with UC-San Francisco. He expects Dignity to participate in some fashion in California’s statewide HIE known as the California Integrated Data Exchange, or Cal INDEX.

Physicians seem to welcome the efforts, as long as HIE fits workflow and makes practitioners more efficient. “I haven’t seen any resistance from physicians when we give them data,” Lundquist said.

Eventually, he would like to push alerts to clinicians to encourage early interventions with high-risk patients. “There needs to be a benefit to the doctor and the patient for them to do something outside their traditional workflow,” Lundquist said.

“Obviously, it’s important to integrate as much clinical data as possible,” said Lundquist, who reports to both the CIO and to physician integration team leaders. That is easier with employed doctors than with independent physicians, who have all sorts of EHRs at various levels of implementation and sophistication. “Some small vendors don’t even have strong CCD outputs yet,” Lundquist said, referring to the Continuity of Care Document format required in Meaningful Use Stage 1. (Stage 2 replaces CCD with an HL7 standard called the Consolidated Clinical Document Architecture.)

The Best Is Yet To Come

Stage 1, which about 90 percent of hospitals and 70 percent of individual clinicians in the U.S. have met, was about getting EHRs in place. With that in mind, CHIME’s Branzell is optimistic. “We have a lot of exchange going on in a lot of places that wasn’t there 4 to 5 years ago,” he said.

“We’re building a house. We’ve got a beautiful foundation now,” Branzell said. “But you can’t live in a foundation.” Right now, the nation’s healthcare organizations are “just starting to put up the walls,” he added.

“Huge gains in efficiency and safety were not supposed to come until post-Stage 3,” Branzell said. That will be in about 2020, or the sixth year of ONC’s new 10-year vision. “It’s not all doom and gloom,” Branzell said.

In January 2014, the American Board of Internal Medicine (ABIM) changed its certification policies for physicians. Instead of being listed by the ABIM as “certified,” physicians are now listed as “certified, meeting maintenance of certification (MOC) requirements” or “certified, not meeting MOC requirements.” MOC requirements include ongoing engagement in various medical knowledge, practice-assessment, and patient-safety activities, on which physicians are assessed every 2 years, and passage of a secure exam in one’s specialty every 10 years.

My personal frustration in trying to fulfill the new MOC requirements ultimately led me to create a Web-based petition that now has more than 19,000 anti-MOC signatures and contains thousands of comments against the new MOC requirements (www.nomoc.org). A recent second petition with nearly 6000 signatures advocates taking a “pledge of noncompliance” with the requirements.

Although the ABIM argues that there is evidence supporting the value of MOC, high-quality data supporting the efficacy of the program will be very hard, if not impossible, to obtain. In fact, close examination of the reports cited by the ABIM reveals that the data are ambiguous at best: in a meta-analysis of 33 studies, 16 described a significant association between certification status and positive clinical outcomes, 14 found no association, and 3 found a negative association. Moreover, the authors of the meta-analysis concluded that the research methods of most published studies on this topic are inadequate.1 Almost all published studies evaluate initial board certification, not recertification or MOC,2 and the rigorous requirements for initial certification should not be equated with the busywork required for the MOC every 2 years. One of the few studies examining lapsed certification showed no effect of physicians’ certification status on patient outcomes after coronary intervention.3 Two very recent studies found no association between recertification and performance or quality measures; one, conducted by ABIM members, found a minor reduction in cost of care.4 No study provided level A data, and these findings relate only to recertification, not the controversial new MOC requirements.

The ABIM claims that a majority of certified physicians have already signed up for MOC, which they interpret as support for the program, but MOC is mandated by the ABIM for recently certified physicians and perceived as a job-security requirement by many others — physician interest is either required or motivated by fear. Indeed, in a 2010 Journal feature that allowed physicians to express their opinions on MOC, many respondents commented that “the exercise was only marginally relevant to their day-to-day practice and that it took their time away from patients and other learning activities.”5 These problems are especially frustrating in light of other ongoing tasks that hospital-based physicians are required to complete. For example, to maintain my hospital privileges I must complete 14 separate computer modules on various subjects either annually or every 2 years. In addition, my annual bonus is tied to my performance on practice-improvement activities, including formal surveys of patient satisfaction, low-density lipoprotein cholesterol control, blood-pressure control, and various core measures for hospitalized patients. Adding continuous ABIM MOC activities, which have no documented efficacy, to this already overwhelming list is onerous and diminishes the time physicians have for patient care.

Although some members of the medical community believe that it’s not unreasonable to ask physicians to formally document their fund of knowledge every 10 years, others strongly believe that the exam questions are not relevant to their practice or a reliable gauge of physicians’ knowledge. The ABIM describes its tests as using “psychometrics” leading to “high reliability and reproducibility,”2 but no clear correlation between these test results and patient outcomes has been documented. Furthermore, many physicians believe that closed-book tests are no longer relevant, since physicians can now easily turn to online resources, as well as their colleagues, while caring for patients.

The ABIM has grown into a large business enterprise. The economics of certification are exposed on the ABIM’s Internal Revenue Service Form 990, which is required of all not-for-profit organizations (www.guidestar.org). In 2012, the year of its latest filing, the ABIM received more than $55 million in fees from physicians seeking certification. Several of its board members and its chief executive officer are highly compensated. Many respondents to the Journal feature expressed the view that “the MOC program was essentially a money-generating activity for the ABIM.”5 Much of the U.S. health care system is now focused on value, and physicians are working hard to provide better patient care at lower cost. MOC provides the opposite — an activity with no proven efficacy, at a high cost. MOC fees range from $2,715 to $3,335 every 10 years; on top of these are costs for travel to testing centers, review courses, and time spent away from practice. I believe that, like the rest of the medical community, the ABIM should focus on efficacy while cutting its costs and lowering its fees.

We all support lifelong learning, but an excellent alternative to MOC already exists: continuing medical education (CME). Currently, medical licensure for physicians requires an annual minimum of approximately 25 hours of CME, depending on the state. Physicians accept this requirement because they perceive it as having value. Organizations providing recognized CME programs are regulated by the Accreditation Council for Continuing Medical Education, which requires each CME offering to provide an “educational gap analysis,” a needs assessment, information about speakers’ potential conflicts of interest, and course evaluations, as well as meeting other performance standards. CME offerings must compete with one another, and they therefore provide choice. If physicians do not perceive value in a particular CME offering, they will go elsewhere — a situation in stark contrast with the ABIM monopoly on MOC.

There are many opinions about how MOC should be changed. My main recommendation would be to allow 25 annual hours of CME to be substituted for the current MOC requirements that need to be met every 2 years. Doing so would eliminate, or make optional, the busywork modules that have little practical value, including all medical knowledge, practice-improvement, and patient-safety modules. The charges for these new MOC activities should be nominal — perhaps $100 per year for tracking a physician’s annual CME attendance. I also believe that the ABIM website should be vastly simplified so that administrative tasks become less onerous. Finally, I believe that the ABIM should work to cut its costs and, correspondingly, substantially reduce the initial certification and recertification fees paid by physicians.

The ABIM is now under fire. Some 63% of respondents to the 2010 Journal feature opposed MOC.5 In a survey by the American College of Cardiology (ACC), nearly 90% of the respondents opposed the new MOC requirements, and ACC leaders are now engaged in discussions with the ABIM to change MOC. The ABIM has been formally criticized for the new requirements by several important physician groups, including the American College of Physicians and the American Association of Clinical Endocrinologists (which has formally asked the ABIM to “suspend its new MOC requirements”). The Association of American Physicians and Surgeons filed a lawsuit against the American Board of Medical Specialties (the parent organization of the ABIM) for restraining trade and causing a reduction in patient access to physicians. At a recent American Medical Association meeting in Chicago, delegates voted to oppose making MOC mandatory as a condition of medical licensure.

Regardless of how the MOC issue is resolved, the recent focus on the ABIM has shed a bright light on how medicine is regulated in the United States. The ABIM is a private, self-appointed certifying organization. Although it has made important contributions to patient care, it has also grown into a $55-million-per-year business, unfettered by competition, selling proprietary, copyrighted products. I believe we would all benefit if other organizations stepped up to compete with the ABIM, offering alternative certification options.

More broadly, many physicians are waking up to the fact that our profession is increasingly controlled by people not directly involved in patient care who have lost contact with the realities of day-to-day clinical practice. Perhaps it’s time for practicing physicians to take back the leadership of medicine.

How a consumer genetics company amassed a database of willing research participants.

Facebook generates about $8 a year in revenue from each of its users. But what if you offered a company not just your photos and updates, but your entire genome?

Then you could be worth as much as $20,000.

That’s my rough calculation for what Genentech could pay direct-to-consumer gene testing company 23andMe for the chance to trawl the DNA of each of several thousand of its customers for genetic clues to Parkinson’s disease.

The deal between the two companies, announced today, provides some fascinating insights into the evolving DNA business and the commercial prospects for 23andMe, a high-flying company that’s had some problems in the U.S. with regulators. According to detailed coverage over at Forbes, Genentech will pay as much as $60 million for access to 3,000 Parkinson’s patients in 23andMe’s database.

The backstory is that 23andMe pioneered direct-to-consumer genetic tests starting in 2006. It asked consumers to spit in a tube and send it in, and sent back a detailed summary of their risks for common diseases like macular degeneration. But then in 2013 the U.S. Food & Drug Administration banned the test out of concern that the information wasn’t accurate.

That put a big crimp in 23andMe’s business, but it didn’t end it. As Forbes points out, the real business here is mining this data:

Such deals, which make use of the database created by customers who have bought 23andMe’s DNA test kits and donated their genetic and health data for research, could be a far more significant opportunity than 23andMe’s primary business of selling the DNA kits to consumers. Since it was founded in 2006, 23andMe has collected data from 800,000 customers and it sells its tests for $99 each. That means this single deal with one large drug company could generate almost as much revenue as doubling 23andMe’s customer base.

The company hasn’t stopped gathering DNA data either. It still sells its Personal Genome Service health kits in countries like Canada. In the U.S. it continues to offer a more limited genealogy test to people who want to learn what their DNA says about their ancestry and relatives.

The result is that 23andMe may have the largest DNA database anywhere that’s open for medical studies. Of its 820,000 customers, the company says, about 600,000 have also agreed to donate their DNA data for research purposes. According to Forbes:

“I think that this illustrates how pharma companies are interested in the fact that we have a massive amount of information,” says Anne Wojcicki, 23andMe’s chief executive and co-founder. “We have a very engaged consumer population, and these people want to participate in research.”

It’s also a reminder that 23andMe’s real business isn’t selling $99 tests, but selling access to data that it has managed to crowdsource as cleverly as Facebook has gathered other personal details. To some observers, that’s pretty worrisome. In 2013, journalist Charles Seife, writing in Scientific American, called 23andMe intentions “terrifying.”

As the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.

Seife’s worry is that the consents customers agree to when they donate their DNA could turn out to be meaningless. Once you are hooked, companies like Google and Facebook often change their privacy policies to expose more and more of your data. Why should DNA be any different?

So far, 23andMe seems more sincere than sinister. Parkinson’s disease is personally important to Wojcicki and her husband, Google founder Sergey Brin: his mother was diagnosed with the disease, which runs in families. Todd Sherer, the head of the Michael J. Fox Foundation for Parksinon’s Research, told me that the couple (now separated) has been the organization’s biggest donor, giving more than $150 million.

But Seife is right about the economics of DNA. It’s collecting free-and-clear data and amassing willing users that counts. According to the Fox Foundation, 23andMe actually gave its testing service away to Parkinson’s patients. That helped it assemble enough of them to create a useful resource it could sell to Genentech to start mining.

As part of its research, Genentech will gain access to the stored spit samples of 3,000 Parkinson’s patients in order to access their full genomic information. That is something that is allowed by the agreements customers signed. But to make sense of the DNA data, Genenetech will also need a lot of extra information about people’s health situations and medical records.

In this case, Forbes reports, the company will be reaching out to them to craft new agreements to access that, too.